TECHFIT DISRP® System

K230276 · Techfit Digital Surgery · DZJ · Jun 23, 2023 · Dental

Device Facts

• Record ID: K230276
• Device Name: TECHFIT DISRP® System
• Applicant: Techfit Digital Surgery
• Product Code: DZJ · Dental
• Decision Date: Jun 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2

Intended Use

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options. The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

Device Story

Web-based collaboration platform for orthognathic surgery planning; manages case flow between surgeons, sales reps, and TECHFIT planning staff. Inputs: DICOM data from CT/CBCT scanners; STL surface scan data. Processing: 3D visualization, bone fragment manipulation (translation/rotation), and surgical simulation. Outputs: Digital models (STL) for rapid prototyping of patient-specific surgical guides and splints; osteosynthesis plate lists. Guides are either 3D-printed (Biomed Clear Resin) or machined (CP Titanium Grade 4). Used in clinical settings; operated by surgeons and planning staff. Benefits: Facilitates precise surgical planning, improves transfer of pre-surgical plans to the OR, and assists in correct bone/implant positioning.

Clinical Evidence

Bench testing only. Includes sterilization validation (AAMI/ISO 17665-1, ANSI/AAMI/ISO 14937), dimensional validation, mechanical testing (bending/compressive strength), compatibility testing with maxillofacial systems, and comprehensive biocompatibility testing (ISO 10993-5, -10, -11, -18, -17, -3) for both resin and titanium components. Software verified and validated per IEC 62304.

Technological Characteristics

Web-based software platform; 3D printing (SLA) using Biomed Clear Resin; subtractive machining of CP Titanium Grade 4. Connectivity: Networked/Cloud-based. Sterilization: Steam (non-sterile delivery). Software: Rule-based planning and segmentation algorithms. Dimensions: Patient-specific.

Indications for Use

Indicated for adults undergoing maxillofacial surgery, including Le Fort and Genioplasty procedures, requiring surgical guides and splints for bone positioning and osteotomy guidance.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• KLS Martin Individual Patient Solutions (IPS) Planning System (K182789)

Reference Devices

• IPS CaseDesigner 2.0 (K200810)
• TECHFIT Patient-Specific Maxillofacial System (K203282)
• AFFINITY Proximal Tibia System (K220199)

Submission Summary (Full Text)

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June 23, 2023

TECHFIT Digital Surgery Angela María Lema-Pérez Regulatory Affairs Specialist 1511 Aviation Center Pkwy Suite 220H Daytona Beach, Florida 32114

Re: K230276

Trade/Device Name: TECHFIT DISRP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 30, 2023 Received: May 30, 2023

Dear Angela María Lema-Pérez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230276

Device Name TECHFIT DISRP® SYSTEM

### Indications for Use (Describe)

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

#### K230276 - 510(k) summary 1

The 510(k) summary is provided on the following page per 21 CFR 807.92(c).

# 510(k) summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

#### 1.1 Submitter information

Table 1. Submitter information

| Company name | TECHFIT Digital Surgery |
|-----------------------------------|-----------------------------------------|
| Establishment registration number | 3004187715 |
| Street Address | 1511 Aviation Center Pkwy<br>Suite 220H |
| City | Daytona Beach |
| Zip code | FL 32114 |
| Country | United States |
| Phone number | [phone] Ext. 165 |
| Fax number | [phone] |
| Principal contact person | Angela María Lema-Pérez |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | [e-mail] |
| Additional contact person | Susana Muñoz-Cuartas |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | [e-mail] |

#### 1.2 Date Prepared

June 22, 2023.

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Image /page/4/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a white semi-oval shape partially covering it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.

#### 1.3 Submission information

| Table 2. Submission information | |
|------------------------------------------|-----------------------|
| Trade name | TECHFIT DISRP® SYSTEM |
| Common or Usual name | DISRP |
| Classification name | 21 CFR 872.4120 |
| Product code (classification regulation) | DZJ, LLZ |
| Classification Panel | Dental |
| Device class | Class II |

#### 1.4 Predicate device

The primary devices to which substantial equivalence is claimed to:

| Table 3. Primary predicate device | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------|
| Primary predicate: KLS Martin Individual Patient Solutions (IPS) Planning system | |
| Trade or proprietary or model name | KLS Martin Individual Patient Solutions (IPS) Planning System |
| 510(k) number | K182789 |
| Decision date | 2019/03/11 |
| Product code | DZJ, LLZ |
| Manufacturer | KLS-Martin L.P. |

# Table 3. Primary predicate device

#### 1.5 Reference devices

The general information of the reference devices is the following:

| | | | Table 4. Reference Device 1 | | |
|--|--|--|-----------------------------|--|--|
|--|--|--|-----------------------------|--|--|

| Secondary predicate: IPS CaseDesigner 2.0 | |
|-------------------------------------------|----------------------|
| Trade or proprietary or model name | IPS CaseDesigner 2.0 |
| 510(k) number | K200810 |
| Decision date | 2020/10/08 |
| Product code | LLZ |
| Manufacturer | Nobel Biocare AB |

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Image /page/5/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray, tear-drop-shaped object overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in gray, block letters, with the words "Digital Surgery" in a smaller font below.

# Table 5. Reference Device 2

| Reference device 1: TECHFIT Patient-Specific Maxillofacial System | |
|-------------------------------------------------------------------|-----------------------------------------------|
| Trade or proprietary or model name | TECHFIT Patient-Specific Maxillofacial System |
| 510(k) number | K203282 |
| Decision date | 2021/05/19 |
| Product code | JEY |
| Manufacturer | TECHFIT Digital Surgery INC. |

# Table 6. Reference Device 3

| Reference device 2: AFFINITY Proximal Tibia System | |
|----------------------------------------------------|-----------------------------------|
| Trade or proprietary or model name | AFFINITY Proximal Tibia System |
| 510(k) number | K220199 |
| Decision date | 2022/03/21 |
| Product code | HRS, HWC |
| Manufacturer | Industrias Medicas Sampedro S.A.S |

#### 1.6 Device Information

Table 7 presents the device information of the subject device and predicate devices.

| | Subject device:<br>TECHFIT<br>SYSTEM<br>DISRP® | Primary predicate device:<br>KLS Martin Individual<br>Patient Solutions (IPS)<br>Planning System<br>(K182789) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | DZJ, LLZ | DZJ, LLZ |
| Classification | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 872.4120,<br>Class II<br>21 CFR 892.2050,<br>Class II |
| Intended Use | TECHFIT Digitally Integrated<br>Surgical Reconstruction<br>Platform (DISRP) System is<br>intended for use as a software<br>system and image<br>segmentation system for the<br>transfer of imaging<br>information from a medical | The KLS Martin<br>Individual Patient<br>Solutions (IPS)<br>Planning System is<br>intended for use as a<br>software system and<br>image segmentation |

# Table 7. Device information

510(k) Premarket Notification

TECHFIT DIGITAL SURGERY

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Image /page/6/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue and gray sphere on the left, followed by the word "TECHFIT" in gray, sans-serif font. Below "TECHFIT" is the phrase "Digital Surgery" in a smaller, gray, sans-serif font. The logo is clean and modern, and the colors are professional and calming.

#### 1.6.1 Device Description

# The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).

# Digitally Integrated Surgical Reconstruction Platform (DISRP)

The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.

# Orthognathic Surgical Guides

| 510(k) Premarket Notification | TECHFIT DIGITAL SURGERY |
|-------------------------------|-------------------------|
|-------------------------------|-------------------------|

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Image /page/7/Picture/1 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a smaller, gray sphere partially overlapping it on the left side. To the right of the spheres, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.

Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.

Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.

- Resin Orthognathic Surgical Guides ●
Resin Orthognathic Surgical Guides include surgical guides and splints.

Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.

The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

- Machined Orthognathic Surgical Guides .
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.

# 1.6.2 Indications for use

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including

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Image /page/8/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.

surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

#### 2 Comparison to Predicate Devices

Both subject device and primary predicate have the same indications for use: orthognathic surgery, including Le Fort and Genioplasty Surgical Guides and splints, reconstructive surgery, and trauma of the midface and maxillofacial skeleton. A device comparison table is more detailed in section 12 and Table 8.

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Image /page/9/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, all-caps letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

# Table 8. Comparison to predicate device - an overview.

| Criteria | Subject device | Primary predicate | Reference device 1 | Reference device 2 | Reference device<br>3 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K number | TECHFIT DISRP®<br>SYSTEM | KLS Martin Individual<br>Patient Solutions (IPS)<br>Planning System | IPS CaseDesigner<br>2.0 | TECHFIT Patient-<br>Specific<br>Maxillofacial<br>system | AFFINITY<br>Proximal Tibia<br>System |
| 510K number | K230276 | K182789 | K200810 | K203282 | K220199 |
| Indications for<br>Use | TECHFIT Digitally<br>Integrated Surgical<br>Reconstruction Platform<br>(DISRP) System is<br>intended for use as a<br>software system and<br>image segmentation<br>system for the transfer of<br>imaging information from<br>a medical scanner such<br>as a CT based system.<br>The input data file is<br>processed by the DISRP<br>System and the result is<br>an output data file that<br>may then be provided as<br>digital models or used as<br>input to a rapid<br>prototyping portion of the<br>system that produces<br>physical outputs including<br>surgical guides and splints<br>for use in maxillofacial<br>surgery. The DISRP<br>System is also intended<br>as a pre-operative<br>software tool for<br>simulating / evaluating<br>surgical treatment options. | The KLS Martin<br>Individual Patient<br>Solutions (IPS) Planning<br>System is intended for<br>use as a software system<br>and image segmentation<br>system for the transfer of<br>imaging information from<br>a medical scanner such<br>as a CT based system.<br>The input data file is<br>processed by the IPS<br>Planning System, and the<br>result is an output data<br>file that may then be<br>provided as digital<br>models or used as input<br>to a rapid prototyping<br>portion of the system that<br>produces physical<br>outputs including<br>anatomical models,<br>guides, splints, and case<br>reports for use in<br>maxillofacial surgery. The<br>IPS Planning System is<br>also intended as a pre-<br>operative software tool | IPS CaseDesigner is<br>indicated for use as a<br>software and image<br>segmentation system<br>for the transfer of<br>imaging information<br>from a scanner such<br>as a CT scanner. It is<br>also indicated to<br>support the diagnostic<br>and treatment<br>planning process of<br>craniomaxillofacial<br>procedures. IPS<br>CaseDesigner<br>facilitates the service<br>offering of<br>individualized surgical<br>aids. | TECHFIT Patient-<br>Specific Maxillofacial<br>System is intended<br>for use in the<br>stabilization, fixation,<br>and reconstruction of<br>the<br>maxillofacial/midface<br>and mandibular<br>skeletal regions. | AFFINITY Proximal<br>Tibia System is<br>intended to treat<br>fractures,<br>nonunions,<br>malunions of the<br>proximal tibia<br>including simple,<br>comminuted,<br>lateral wedge<br>depression, medial<br>wedge, bicondylar<br>combination of<br>lateral wedge and<br>depression,<br>periprosthetic, and<br>fractures with<br>associated shaft<br>fractures.<br>-Simple<br>metaphyseal<br>fractures<br>(Classification AO<br>41-A2)<br>-Multifragmentary<br>metaphyseal<br>fractures<br>(Classification AO |

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Image /page/10/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray crescent shape partially covering it on the left side. To the right of the sphere is the word "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below it.

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Image /page/11/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a white teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in a simple, sans-serif font, and below that is the phrase "Digital Surgery" in a smaller font.

| The DISRP system is<br>compatible with the<br>TECHFIT Patient- Specific<br>Maxillofacial System and<br>the TECHFIT Diagnostic<br>Models and should be<br>used in conjunction with<br>expert clinical judgment | surgical treatment<br>options. | | | -Simple bicondylar<br>fractures<br>(Classification<br>AO41-C1, 41-C2)<br><br>-Multifragmentary<br>bicondylar<br>fractures<br>(Classification AO<br>41-C3)<br><br>-Simple joint<br>simple<br>metaphyseal<br>fractures<br>(Classification AO<br>41-C1)<br><br>-Diaphisary<br>fractures<br>(Classification AO<br>42A and 42B) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Clinical Use | Orthognathic treatment | Maxillofacial and<br>orthognathic treatment | Cranio-maxillofacial<br>and orthognathic<br>treatment | Maxillofacial/<br>Midface & Mandible | Orthopedic<br>Proximal tibial<br>condyles |
| Product Code | DZJ, LLZ | DZJ, LLZ | LLZ | JEY | HRS, HWC |

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Image /page/12/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT" the words "Digital Surgery" are written in a smaller font.

| Classification | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 892.2050,<br>Class II | 21 CFR 872.4760,<br>Class II | 21 CFR 888.3030,<br>Class II |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Target<br>Population | Adults | Pediatric & Adults | Adults | Adults | Adults |
| Image Import | DICOM data format from<br>CT/CBCT scanner<br>3D models and surface<br>scan data in generic open<br>file format (STL) | DICOM data format from<br>CT scanner 3D models<br>and surface scan data in<br>generic open file format<br>(STL). | DICOM data format<br>from CT/CBCT<br>scanner<br>3D models and<br>surface scan data in<br>generic open file<br>format (STL) | DICOM data format<br>from CT/CBCT<br>scanner<br>3D models and<br>surface scan data in<br>generic open file<br>format (STL) | No |
| Software<br>output | Encrypted STL file with<br>design of the final patient<br>specific device such as<br>surgical guides, splints<br>and case reports | N.A. | Encrypted STL file<br>with design of the final<br>splint for centralized<br>manufacturing at KLS<br>Martin | N.A | N.A |
| | 3D Visualization | 2D and 3D Visualization | 2D and 3D<br>Visualization | N.A | N.A |
| | Distance and angle<br>measurements | Distance and angle<br>measurements | Distance and angle<br>measurements | N.A | N.A |
| Software<br>functions | Bone fragments can be<br>moved in the 3D space<br>(translations and<br>rotations) in order to plan<br>the ideal post-operative<br>position of each fragment.<br>Supported osteotomies:<br>Le Fort I, Chin, Splint | Bone fragments can be<br>moved in the 3D space<br>(translations and<br>rotations) in order to plan<br>the ideal post-operative<br>position of each<br>fragment.<br>Supported osteotomies:<br>Le Fort I, Sagittal, Splint,<br>Ramus, Chin | Bone fragments can<br>be moved in the 3D<br>space (translations<br>and rotations) in order<br>to plan the ideal post-<br>operative position of<br>each fragment.<br>Supported<br>osteotomies:<br>Le Fort I, Sagittal,<br>Splint, Ramus, Chin,<br>Segmental (Split, Y-<br>cut, H-cut) | N.A | N.A |
| | 3D Surgical Model<br>creation from CBCT/CT<br>scan data and STL file | 3D Surgical Model<br>creation from<br>CT scan data | 3D Surgical Model<br>creation from<br>CBCT/CT scan data<br>and STL file | N.A | N.A |
| Software<br>functions | 3D photo mapping | Soft tissue simulation | Soft tissue simulation,<br>3D photo mapping | N.A | N.A |

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Image /page/13/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.

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Image /page/14/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere and teardrop is the word "TECHFIT" in gray, block letters, with the words "Digital Surgery" in a smaller font below it.

| Based on the created<br>orthognathic plan the user<br>can export surgical guides<br>and splints order files.<br>These files can be used to<br>calculate and produce<br>orthognathic surgical<br>guides and splints in the<br>production backend | Based on the created<br>orthognathic plan the<br>user can export surgical<br>splint order files. These<br>files can be used to<br>calculate and produce<br>orthognathic splints in the<br>production backend | Based on the created<br>orthognathic plan the<br>user can export<br>surgical splint order<br>files. These files can<br>be used to calculate<br>and produce<br>orthognathic splints in<br>the production<br>backend | N.A | N.A |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----|
| DISRP: the user can<br>create a list of required<br>osteosynthesis plates<br>based on a created<br>surgical plan. | N.A. | Osteosynthesis Plates<br>& IPS Gate: the user<br>can create a list of<br>required<br>osteosynthesis plates<br>based on a created<br>surgical plan. | N.A | N.A |

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Image /page/15/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, uppercase letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

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Image /page/16/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.

| | - New algorithm for<br>occlusion alignment<br>- New algorithm for virtual<br>occlusion | N.A. | New algorithm<br>for occlusion<br>alignment - New<br>algorithm for<br>virtual<br>occlusion | N.A | N.A |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------|-------------|
| Operating<br>system<br>requirements | Operating system:<br>Windows 64-bit (Windows<br>7 and/or later)<br>Mac OS (Yosemite or<br>later) | Windows 64-bit<br>(Windows 7, 8,<br>10)<br>Mac OS X (Yosemite, El<br>Capitan) | Windows 64-bit<br>(Windows 7, 10)<br>Mac OS Catalina,<br>Mojave, High Sierra | N.A | N.A |
| Material | Resin Orthognathic<br>Surgical guides: Biomed<br>Clear Resin.<br>Machined Orthognathic<br>Surgical Guides: CP<br>Titanium.<br>Metal sleeves: CP<br>Titanium. | Anatomical Models:<br>Epoxy/Resin, Acrylic<br>Cutting/Marking Guides:<br>Polyamide, Titanium Alloy<br>(Ti-6Al-4V), CP Titanium<br>Splints: methacrylate | Not available | CP Titanium | CP Titanium |

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Image /page/17/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray crescent shape partially overlapping it on the left side. To the right of the sphere and crescent is the word "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below it.

| Manufacturing<br>Method | Resin: 3D printing -<br>Stereolithography (SLA).<br>CP Titanium: Traditional<br>(Subtractive) | Epoxy/Resin, Acrylic:<br>Stereolithography (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive;<br>Selective Laser Melting)<br>Polyamide: 3D (Additive;<br>Selective Laser Sintering) | Not available | Traditional<br>(Subtractive) | Traditional<br>(Subtractive) |
|----------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Not available | Non-sterile (Steam) | Non-sterile<br>(Steam) |
| Manufacturer | TECHFIT Digital Surgery | KLS Martin | Nobel Biocare | TECHFIT Digital<br>Surgery | Industrias Médicas<br>Sampedro |
| Patient-<br>specific<br>configuration? | Yes. Devices are<br>manufactured patient-<br>specific, based on a CT<br>scan of the patient | Yes. Devices are<br>manufactured patient-<br>specific, based on a CT<br>scan of the patient | Yes | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | No. The plates are<br>standard<br>manufactured<br>plates |

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Image /page/18/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in gray, all-caps lettering. Below "TECHFIT" are the words "Digital Surgery" in a smaller, gray font.

#### 3 Performance data

The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:

| Name | Test method | Conclusion |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety testing | | |
| Validating sterilization<br>methods | AAMI/ISO 17665-1:2006/(R)2013<br>Sterilization of health care products<br>- Moist heat - Part 1 Requirements<br>for the development, validation and<br>routine control of a sterilization<br>process for medical devices.<br>ANSI/AAMI/ISO<br>14937:2009/(R)2013 Sterilization of<br>Healthcare Products -General<br>Requirements for Characterization<br>of a Sterilizing Agent and the<br>Development, Validation and<br>Routine Control of a Sterilization<br>Process for Medical Devices. | The results of the steam<br>sterilization validation<br>show that TECHFIT<br>Orthognathic Surgical<br>Guides sterilized to a<br>SAL of 10-6 using the<br>recommended steam<br>sterilization instructions |
| Performance testing | | |
| Dimensional validation | Scanning of orthognathic surgical<br>guides and then comparing them<br>versus the original files, before and<br>after sterilization. | DISRP and<br>Orthognathic surgical<br>guides maintain the<br>proportions and<br>dimensions of the<br>original digital design<br>after manufacturing and<br>sterilization. |
| Mechanical testing | Bending and compressive strength,<br>after sterilization. Evaluating if the<br>orthognathic surgical guides can<br>withstand the maximum bite force,<br>force required for drilling and handle<br>force required for a general surgery. | Orthognathic Surgical<br>Guides withstand bit<br>force and the force<br>applied by the surgeon<br>during handling. |
| Compatibility testing | Verifying compatibility between the<br>Maxillofacial System and<br>orthognathic surgical guides | Orthognathic Surgical<br>Guides are compatible<br>with the Maxillofacial<br>System and Metal<br>Sleeves. |
| Software testing | Software verification and validation<br>activities | DISRP software was<br>verified and validated as<br>per IEC 62304 |

### Table 9. Performance data

TECHFIT DIGITAL SURGERY

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Image /page/19/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, all-caps letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

- Biocompatibility testing .
Resin Orthognathic Surgical Guides are manufactured with Biomed Clear (Formlabs). The following are the tests summarizes the biocompatibility testing:

| | Table 10. Overview of Biomed Clear biocompatibility testing | | | | |
|--|-------------------------------------------------------------|--|--|--|--|
|--|-------------------------------------------------------------|--|--|--|--|

| Test / Assessment Description | Test Report Conclusion |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity:<br>ISO 10993-5 | No cytotoxic effect properties in<br>compliance with requirements of<br>the ISO 10993-5 guidelines |
| Sensitization:<br>ISO 10993-10 | No sensitizing properties in<br>compliance with requirements of<br>the ISO 10993-10 guidelines |
| Irritation:<br>ISO 10993-10 | No irritant properties in compliance<br>with requirements of the ISO<br>10993-10 guidelines |
| Acute systemic toxicity:<br>ISO 10993-11 and USP <88> | No evidence of systemic toxicity<br>test passed and is considered<br>negative based on standards set by<br>ISO 10993-11 |
| Pyrogenicity:<br>ISO 10993-11 | No pyrogenic properties in<br>compliance with requirements of<br>the ISO 10993-11 |
| Chemical Characterization and risk<br>assessment:<br>ISO 10993-18 and ISO 10993-17 | Non-toxic chemical characterization<br>as per ISO 10993-18 and ISO<br>10993-17 standards |

An overview of TECHFIT's biocompatibility testing is shown below:

# Table 11. Overview of TECHFIT biocompatibility testing for Resin Orthognathic Surgical Guides

| Test / Description | Assessment | Test Report Conclusion |
|--------------------------------|------------|----------------------------------------------------------------------------------------------|
| Cytotoxicity:<br>ISO 10993-5 | | No cytotoxic effect properties in compliance with requirements of the ISO 10993-5 guidelines |
| Sensitization:<br>ISO 10993-10 | | No sensitizing properties in compliance with requirements of the ISO 10993-10 guidelines |
| Irritation:<br>ISO 10993-23 | | No irritant properties in compliance with requirements of the ISO 10993-10 guidelines |

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Image /page/20/Picture/0 description: The image shows the Techfit Digital Surgery logo. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, with the words "Digital Surgery" written in a smaller font size below it.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with commercially pure Titanium grade 4. The following are the tests summarizes the biocompatibility testing:

### Table 12. Overview of TECHFIT biocompatibility testing for Machined Orthognathic Surgical Guides and Metal Sleeves.

| Test / Assessment Description | Test Report Conclusion |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity:<br>ISO 10993-5 | No cytotoxic effect properties in<br>compliance with requirements of<br>the ISO 10993-5 guidelines |
| Sensitization:<br>ISO 10993-10 | No sensitizing properties in<br>compliance with requirements of<br>the ISO 10993-10 guidelines |
| Irritation:<br>ISO 10993-10 | No irritant properties in compliance<br>with requirements of the ISO<br>10993-10 guidelines |
| Acute systemic toxicity:<br>ISO 10993-11 | No evidence of systemic toxicity<br>test passed and is considered<br>negative based on standards set by<br>ISO 10993-11 |
| Pyrogenicity:<br>ISO 10993-11 | No pyrogenic properties in<br>compliance with requirements of<br>the ISO 10993-11 |
| Genotoxicity:<br>ISO 10993-3 | No genotoxicity properties in<br>compliance with requirements of<br>the ISO 10993-3 |
| Chemical Characterization and risk<br>assessment:<br>ISO 10993-18 and ISO 10993-17 | Non-toxic chemical characterization<br>as per ISO 10993-18 and ISO<br>10993-17 standards |

#### 4 Conclusion

Non-clinical tests demonstrate that the DISRP System is substantially equivalent to the predicate devices.